Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04413747
Status:
UNKNOWN
Last Update Posted:
2020-08-07
First Post:
2020-05-29
Brief Title:
Yoga Pranayama Adjuvant to Treat Burden COVID-19
Sponsor:
Health Ricerca e Sviluppo SRL
Organization:
Health Ricerca e Sviluppo SRL
Study Overview
Official Title:
Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YOCO
Brief Summary:
COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19 mortality occurs mainly from immunological behavior or by suicide after healing In both cases the causal link is coronavirus within the host response The rationale of use of deep yoga breathing as adjuvant treatment to COVID-19 disease is linked to the mechanical action to stimulate the vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity of action bring to modulate upto suppress the inflammatory reflex and pro-inflammatory cytokines overproduction and contextual lowering of the sympathetic stress response as a first cause of sleep and late mental disorders which can increase the annual suicide rate An easily breathing medical Yoga protocol has been developed to test a cost-effective care provision training contact tracing and mass efficacy testing
Detailed Description:
COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19 pandemic threatens patients societies and healthcare systems around the world Morbidity and lethality have a direct link with the early vicious circles triggered by an acute microcirculation endotheliopathy a correlated coagulopathy up to late hypoxic damage of multi organ tissue The host immunity determines the progress of the disease its lethality and the need of care intensity The clinical course of the infection consist of three stage of which only the third -which intervenes in a low incidence of patients - need of hospitalization for severe hyperinflammatory syndrome including acute respiratory failure while first and the second or moderate pulmonary involvement might manage and monitoring within a homecare program during quarantine Actually the rough mortality in Italy is - at the current date - 76 with an expected death of 0004 of the whole population The late lethality - still little known - from COVID-19 is to be correlated with mental disorders from stress response emerging from the first three COVID-19s stages and which result in a significant increase in suicides that is estimated at 30 more than expected of 74 deaths for 100000 residents This estimate can be considered as stage 4 of the disease or post COVID-19 mortality In this scenario mortality of COVID-19 is by intensity response of the host and in the meantime a cutoff for homecare hospitalization and time-related stress disease Lines of evidence reports that direct-indirect stimulation of vagus nerve bring to the modulating of pro-inflammatory cytokines with effective systemic anti-inflammatory effect and has shown antidepressant effects in chronic treatment resistant depression Because the vagus nerve is linked to brain regions important in anxiety regulation locus coeruleus orbitofrontal cortex insula hippocampus and amygdala this pathway is involved in perceiving various somatic and cognitive symptoms that characterize anxiety and mental disorder disorders On the basis of all these reasoning we plan to introduce a medical based-yoga deep breathing for activation of vagus nerve by scalene and sternocleidomastoid muscles function during breathing as an adjuvant of care of the 1-2 and 4 stages of the COVID-19 disease to counteract the cumulative incidence of mortality and better outcome Medical yoga protocol has been developed and designed to test a cost-effective care provision training contact tracing and mass efficacy testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None